NSK
Report
- Report Number
- 9611253-2024-00023
- Event Type
- Malfunction
- Date Received
- April 30, 2024
- Date of Event
- February 21, 2024
- Report Date
- July 18, 2024
- Manufacturer
- NAKANISHI INC.
- Product Code
- HBC
- PMA / PMN Number
- K132264
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
ON (B)(6) 2024, THE PDS-2TD-15 SURGICAL BUR (LOT NO. 2355) INVOLVED IN THE ADVERSE EVENT WAS RETURNED FROM A DISTRIBUTOR TO NAKANISHI FOR INVESTIGATION. THE LOT NUMBER 2364 IN THE INITIAL REPORT WAS WRONG BECAUSE OF THE DISTRIBUTOR'S MISS COMMUNICATION. UPON RECEIVING THE SURGICAL BUR, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [REPORT NO. C240408-06]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT PDS-2TD-15 SURGICAL BUR [LOT NO. 2355]. THERE WERE NO PROBLEMS OBSERVED DURING ACCEPTANCE/MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE SURGICAL BUR IS A SINGLE USE PRODUCT. B) NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE WITH THE TIP OF THE BUR MISSING. NAKANISHI OBSERVED THE FRACTURE SURFACE AND NOTICED THE FOLLOWING PHENOMENA: - THE BUR WAS FRACTURED AT 14MM FROM THE BACK END. - THERE WERE RATCHET MARKS INDICATING FATIGUE FRACTURE OVER THE ENTIRE FRACTURE SURFACE, WHICH HAD BEEN CAUSED BY TORSIONAL LOAD DURING DRILLING. C) NAKANISHI MEASURED ROCKWELL HARDNESS OF THE RETURNED SURGICAL BUR AND OBSERVED THAT THERE WAS NO ABNORMALITIES IN THE STRENGTH OF THE BUR MATERIALS. D) NAKANISHI ALSO VERIFIED WHETHER A SURGICAL BUR WOULD BE FRACTURED AT DIFFERENT DRILLING ANGLES USING A NEW BUR OF THE SAME MODEL AS THE BUR INVOLVED IN THE ADVERSE EVENT. THE NEW BUR FRACTURED WHEN DRILLING WITH THE BUR TILTED 26 DEGREES, WHICH PROVED THAT THE BUR WAS STRONG ENOUGH SINCE BURS ARE NOT GENERALLY USED AT 26-DEGREE TILT OR MORE. E) NAKANISHI TOOK PHOTOGRAPHS OF ALL THE DISASSEMBLED PARTS AND KEPT THEM IN THE INVESTIGATION REPORT NO. C240408-06. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: A) NAKANISHI DID NOT IDENTIFY THE EXACT CAUSE OF THE RETURNED SURGICAL BUR BEING FRACTURED BECAUSE NAKANISHI WAS NOT ABLE TO PERFORM A FULL EVALUATION OF THE DEVICE INVOLVED IN THE EVENT DUE TO A PART OF THE BUR NOT BEING RETURNED. B) DESPITE OF THE FACT THAT NAKANISHI DID NOT IDENTIFY THE CAUSE, NAKANISHI CONSIDERS THE POSSIBILITY FROM THE RESULTS OF THE VISUAL INSPECTION, THE HARDNESS MEASUREMENT, AND DRILLING VERIFICATION AND FROM MANY YEARS OF EXPERIENCE THAT THE CAUSE OF THE FRACTURED BUR WAS MISUSE BY THE USER. C) IN ORDER TO PREVENT A RECURRENCE OF THE BUR BREAKAGE, NAKANISHI TOOK THE FOLLOWING ACTIONS: C.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED THE CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. C.2) NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DISTRIBUTOR AND DIRECTED THE DISTRIBUTOR TO REMIND THE USER OF THE IMPORTANCE OF USING THE DEVICE AS INSTRUCTED IN THE OPERATION MANUAL.
ON APRIL 8, 2024, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A MALFUNCTION OF A NSK SURGICAL BUR. DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON FEBRUARY 21, 2024. - THE DOCTOR WAS DRILLING A HOLE IN THE REMOVED SKULL CAP OUT OF A PATIENT ON THE TABLE USING A HANDPIECE WITH THE PDS-2TD-15 TWIST DRILLS (LOT NO. 2364). - DURING THE SURGERY, THE DISTAL PART OF THE DRILL BROKE OFF BUT THE PATIENT, USER OR THIRD PARTY WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176007 | NSK | MOTOR, DRILL, ELECTRIC | HBC | NAKANISHI INC. | PDS-2TD-15 | 2355 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |